Global workshop: Transitioning DTwP containing vaccines to animal-free batch release testing strategy. Strategies for implementation.

Online 11:00 - 14:00 CET
29th January 2025

This 2-day (Jan. 29-30, 2024) workshop is part of the Humane Society International (HSI) Project “Accelerate non-animal batch release testing for human vaccines”[1] funded by the Bill & Melinda Gates Foundation.

Within the project, the prioritization of the implementation (or further development) of in vitro opportunities for those vaccines has been highlighted to be a priority by many vaccines manufacturers; and regulatory authorities and NCLs are keen to learn more about those. The project allows stakeholders to have dedicated discussions with experts in the field and join local or global workshops to fill any knowledge gaps and allow additional discussions on prioritizations and resources needed. 

The objective of this workshop is to engage all the industry and regulatory stakeholders in a discussion on the possible strategies to facilitate introduction and acceptance of non animal testing strategies (or animal reduction ones) for the batch release of DTwP containing vaccines, whenever scientifically possible.

The workshop is divided in two days to facilitate the participation of the key stakeholders based all over the world. January 29th will be dedicated to the safety testing discussion and January 30th on the potency.

The ease the dialogue the workshop will provide a quick update on the available opportunities, and the ones that are in development, that can substitute the current safety and potency testing strategies. The dialogue will see the attendees to share and reflect about:

  • their knowledge on those opportunities,
  • their view or experience on the introduction of such opportunities in their local routine testing,
  • what it is needed to move towards updating current local regulations, pharmacopoeias and guidance.

AGENDA January 29thStrategies for updating current animal based safety testing

Time in CETTopicSpeaker
11:00-11:101. Welcome
PRESENTATION SLIDES
Laura Viviani, SciEhiQ
11:10- 11:302. Overview of the opportunities for testing deletion for DTP vaccines  
PRESENTATION SLIDES
Catherine Milne, EDQM    
11:30-12:503. Overview of the opportunities for testing replacement.  

3.1 Diphtheria – Absence of toxin Irreversibility of toxoid: Vero-cells assay (20 min)
PRESENTATION SLIDES

3.2 Tetanus toxicity: BINACLE (20 min)
PRESENTATION SLIDES

3.3 Tetanus toxicity: cell-based assay opportunity and readiness (20 min)
PRESENTATION SLIDES


3.4 The value of the MWGT for wP (20 min)



Pradip Das, Biological E    



Shahjahan Shaid, GSK  


Andrew Peden, Ciara Doran, Sheffield University, and Shalini Rajagopal, MHRA


Pradip Das, Biological E
12:50-13:504. Interactive discussion with speakers and experts and the attendeesAll speakers, Ivana Knezevic and Dianliang Lei, WHO Norms and Standards for Biologicals
13:50-14:005. Closing remarksLaura Viviani, SciEthiQ

AGENDA January 30thStrategies for updating current animal based potency testing

Time in CETTopicSpeaker
11:00-11:101. Welcome
PRESENTATION SLIDES
Laura Viviani, SciEthiQ
11:10- 11:402. DT single dilution or not? Pros and cons of an animal reduction opportunity. NCL and manufacturer’s perspectives. (10 mins each)
2.1 PRESENTATION SLIDES
2.2 PRESENTATION SLIDES
2.3 PRESENTATION SLIDES
Pradip Das, Biological E
Morgane Florens, Sciensano
Silvio Bandiera, Sanofi
11:40-12:303. DTaP in vitro potency test
3.1 Multiplex Assay (20 min)
PRESENTATION SLIDES
3.2 ELISA Assay (20 min)
PRESENTATION SLIDES
Maxime Vermeulen, Sciensano Paul Stickings, MHRA
12:30-12:504. Manufacturers approaches to implementations.
PRESENTATION SLIDES
Sunil Goel, Serum Institute of India with a DCVMN perspective on future implementation
12:50-13:105. wP potency test
5.1 Perspective on future potency testing (10 min)
PRESENTATION SLIDES
5.2 wP bacteria characterization (20 min)
PRESENTATION SLIDES
Laura Viviani, SciEthiQ

Nicholas Mantis, Wadsworth Center, NY State Department of Health
13:10-13:506. Interactive discussion with speakers and experts and the attendeesAll speakers and Ivana Knezevic and Dianliang Lei, WHO Norms and Standards for Biologicals
13:50-14:007. Closing remarksLaura Viviani, SciEthiQ

[1] HSI’s project: https://www.afsacollaboration.org/new-assays-implementation-and-acceptance/